PDF: ExStroke
(2009)Objective
Determine whether repeated verbal instructions can increase long-term physical activity in patients after ischemic stroke.
Study Summary
• Repeated instructions on physical activity over 24 months did not significantly increase activity levels or reduce clinical events in stroke survivors. Alternative, more intensive strategies may be needed.
Intervention
Verbal instruction on a detailed physical activity program at discharge and during 5 follow-up visits over 24 months vs. standard follow-up without activity guidance. Physical activity measured with PASE.
Study Design
Arms: Array
Outcome
• Physical activity (PASE score): 69.1 (intervention) vs. 64.0 (control); difference 5.0 (95% CI −5.8 to 15.9); p=0.36
• No significant difference in mortality, recurrent stroke, MI, or falls/fractures
• No significant difference in mortality, recurrent stroke, MI, or falls/fractures
Bottom Line
Repeated encouragement and verbal instruction in being physically active did not lead to a significant increase in physical activity measured by the PASE score in stroke patients
Major Points
- Multicentre, multinational randomized trial with 314 patients with mild ischaemic stroke
- Intervention consisted of repeated verbal instructions about physical activity over 24 months
- Primary outcome was difference in PASE scores between groups
- No significant difference in PASE scores: 69.1 vs 64.0 (difference 5.0, P=0.36)
- No significant effects on mortality, recurrent stroke, myocardial infarction, or falls
- More intensive strategies needed to promote physical activity after stroke
Study Design
- Study Type
- Randomized controlled trial
- Randomization
- Yes
- Blinding
- Masked outcome assessment - interviewers masked to randomization obtained PASE scores and clinical events, adjudicated by blinded adjudication committee
- Sample Size
- 314
- Follow-up
- 24 months
- Centers
- 8
- Countries
- Denmark, China, Poland, Estonia
Primary Outcome
Definition: Difference in Physical Activity Scale for the Elderly (PASE) score between intervention and control groups
| Control | Intervention | HR/OR | P-value |
|---|---|---|---|
| 64.0 | 69.1 | - (-5.8 to 15.9) | 0.36 |
Limitations & Criticisms
- Only about 15% of stroke patients were recruited, with 15% declining due to reluctance to engage in physical training
- Physiotherapists and investigators were unaware of PASE scores during the trial
- Repeated questioning about physical activity in control group may have increased their PASE scores
- Trial not powered to show effects on recurrent stroke, MI, or survival
- Possible selection bias as some patients declined participation due to lack of interest in physical training
- Most participants had mild strokes limiting generalizability to more severe stroke patients
Citation
BMJ 2009;339:b2810